[Immunogenicity and efficacy of a new recombinant DNA vaccine for hepatitis B virus in Peru].

Approximately 350 million persons are infected with Hepatitis B virus around the world. Peru is one of the countries with high prevalence of Hepatitis B in Latin America and this disease is an important cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma in our country. Vaccination is the only method that has proved to be effective in the control of this disease. This is a prospective, randomized study performed with the purpose of evaluating immunogenicity and efficacy of the Hapavax-Gene vaccine in Peru, a new recombinant DNA vaccine, in healthy persons over 10 years of age. The vaccine was applied intramuscularly, on the deltoid muscle, in 10 microgram doses, to persons between 10 and 19 years of age and 20 microgram doses in persons over 19, using the three doses vaccination scheme: day 0, after 30 days and after 180 days. Out of a total of 188 persons initially admitted for this test, 67 persons completed the study. Immunogenicity was satisfactory: 100% of the participants of Group A (10 to 19 years of age) and 100% of the participants of Group B (over 19). With an arithmetical mean of 28,583.92 mlU/mL and a geometrical mean of 5,754.32 mlU/mL in Group A and an arithmetical mean of 8,708.3 mlU/mL 2 and a geometrical mean of 2,179.32 mlU/mL in Group B. Adverse events accounted for 4.69%, none of which was severe. The recombinant DNA vaccine derived from H. Polymorpha applied in three doses on day 0, after 30 days and after 180 days, is immunogenic and safe in healthy Peruvians over 10 years of age.

RCT Entities:   Population Interventions Outcomes